BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    34IN. (86CM) DISPOSABLE CUFF W/PLC - SP, SB

    MDR report key: 8343720 · Received February 15, 2019

    Report

    Report Number
    0001526350-2019-00104
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    October 5, 2018
    Report Date
    February 20, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    KCY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR THE 34 IN. (86CM) SINGLE PORT SINGLE BLADDER DISPOSABLE CUFF WITH PLC, PART NUMBER 60707510600, REVIEW COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THE REPORTED EVENT. ON 22 JAN 2019, IT WAS REPORTED FROM MEDLINE INDUSTRIES, INC. THAT THREE 34 IN. (86CM) SINGLE PORT SINGLE BLADDER DISPOSABLE CUFFS WITH PLC WERE LEAKING. A RETURNED PRODUCT INVESTIGATION COULD NOT BE PERFORMED FOR THE REPORTED EVENT DUE TO THE PRODUCT NOT BEING RETURNED FOR EVALUATION. THE REPORTED EVENT CAN, THEREFORE, NOT BE CONFIRMED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE CUSTOMER HAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED SEVEN TOURNIQUETS THAT WERE LEAKING. THE TOURNIQUETS WERE FULLY INFLATED AND LEFT ALONE FOR AN HOUR; AFTER THE HOUR THE TOURNIQUETS WERE SIGNIFICANTLY DEFLATED WITH ONE END SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138435 34IN. (86CM) DISPOSABLE CUFF W/PLC - SP, SB TOURNIQUET, PNEUMATIC KCY ZIMMER SURGICAL, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1